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IRCT20211004052670N2 IRCT 2022-01-19 Esfahan University of Medical Sciences The effectiveness of atomoxetine with Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder, and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder Comparative study of the effectiveness of atomoxetine with Ritalin and fluoxetine on anxiety, the severity of attention deficit hyperactivity disorder and the performance of children with ADHD - Attention Deficit Hyperactivity Disorder 2022-02-04 anticipated 100 Complete https://irct.ir/trial/60271 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 100 eligible patients are randomly selected. For this, the letter A is written on 50 sheets, the letter B is written on 50 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups, Blinding description: In order to observe blindness, the drugs are prepared in the same shape before the intervention and are coded and given to the physician. They prescribe them without knowing the type of each drug. Therefore, the patient, the patient, the person recording the clinical and baseline information of the patients as well as the statistical analyst will not be aware of the type of intervention. 2 Attention Deficit Hyperactivity Disorder and Anxiety Disorders. Intervention 1: Intervention group 1: Patients in this group are given Ritalin at a dose of 5 mg twice a day (morning and evening) orally and an increase of 10 mg weekly (until clinical response and parental consent). Fluoxetine also starts at a dose of 2.5-5 mg and is increased weekly until it is eventually increased to a dose of 10 to 20 mg. It is given once a day, often in the morning. Intervention 2: Intervention group 2: Patients in this group start with atomoxetine at a dose of 0.5 mg per kg and increase it weekly to a dose of 1.4 mg per kg. The medicine is given in the morning. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Afsaneh Karbasi Amel
No 7, Berlian deadend , Erfani alley, Azar alley
Isfahan Iran (Islamic Republic of) 8133714131 +98 31 3233 6413 afsanehkarbasi@yahoo.com Esfahan University of Medical Sciences scientific Shahrzad Aghili
No 7, Berlian deadend , Erfani alley, Azar alley
Isfahan Iran (Islamic Republic of) 8133714131 +98 31 3233 6413 aghili.shahrzad@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Students 6 to 12 years old referred to Khorshid Psychiatric Clinic, and Amin Attention Deficit Hyperactivity Disorder and Anxiety Disorder based on DSM-5 Primary age (6 to 12 years) 6 years 12 years Both Having any chronic illness Family history of psychosis and mood disorder in the family first degree F90+F40 Attention-deficit hyperactivity disorders + Phobic anxiety disorders Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in this group are given Ritalin at a dose of 5 mg twice a day (morning and evening) orally and an increase of 10 mg weekly (until clinical response and parental consent). Fluoxetine also starts at a dose of 2.5-5 mg and is increased weekly until it is eventually increased to a dose of 10 to 20 mg. It is given once a day, often in the morning. Intervention group 2: Patients in this group start with atomoxetine at a dose of 0.5 mg per kg and increase it weekly to a dose of 1.4 mg per kg. The medicine is given in the morning. Severity of Anxiety Disorders. Timepoint: Before the intervention, 1 and 4 months after the start of the intervention. Method of measurement: The child and parent Screen for Child Anxiety Related Emotional Disorders (SCARED). Severity of Attention Deficit Hyperactivity Disorder. Timepoint: Before the intervention, 1 and 4 months after the start of the intervention. Method of measurement: Conners' Continuous Performance Test. Performance score. Timepoint: Before the intervention, 1 and 4 months after the start of the intervention. Method of measurement: The Child Anxiety Impact Scale (CAIS). Esfahan University of Medical Sciences Approved 2021-05-16 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)